Plain English Summary
Background and study aims
Obesity is a major problem in the Netherlands. Overweight people are 15% more likely to get sick and are more absent from work than people of normal weight. They also have an increased risk of diabetes and heart disease. It is important that the employer plays an active role in promoting a healthy lifestyle and prevention of obesity in the workplace. To date, few studies have addressed this problem at work and this is the aim of this study. Employees learn skills which they can use to develop a healthier diet. To support the application of the newly learned skills we create an environment where the healthy choice was an easier choice. Employees are encouraged to improve their diet via two different approaches: a self-management course and an environmental intervention. The aim of this study is to find out whether these two approaches can improve healthy eating.
Who can participate?
Companies in the Netherlands were approached through an occupational health service, or they received an email/letter with research information, asking them to participate in research promoting healthy eating. Any company in the Netherlands that employs enough employees to form course groups could participate.
What does the study involve?
After companies agreed to participate in the research, they were first allocated to a condition in which unhealthy foods in the canteen were made less accessible or not. Employees were invited to join by email or by messages on the intranet. They were randomly assigned to the self-management course group or environmental intervention, a group receiving one two-hour group session only. In the self-management course, called Healthy Eating at Work, people learn to set small concrete goals, recognize conditions for and barriers to goal achievement, come up with problem solving strategies in specific challenging situations, formulate action plans and evaluate their progress. In the environmental intervention minor adjustments were made to the presentation of unhealthy foods in the canteen. Unhealthy foods in the canteen were made less accessible by placing them about 40 cm further behind the counter.
What are the possible benefits and risks of participating?
Participants could benefit by improving their diet. Specifically, participants in the self-management course could improve their skills in identifying the difficulties they may encounter when pursuing their goals. These skills can be implemented in many areas. No risks of participation in the study have been identified.
Where is the study run from?
The study was run from various companies in the Netherlands.
When is the study starting and how long is it expected to run for?
The study started early 2009 and was completed by early 2013.
Who is funding the study?
The study is funded by Stichting Instituut GAK, Netherlands.
Who is the main contact?
Mrs Josje Maas
j.maas@uu.nl
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Josje Maas
ORCID ID
Contact details
Heidelberglaan 1
Utrecht
3584 CS
Netherlands
+31 30 253 92 48
j.maas@uu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prevention of obesity at work: a prospective randomized controlled trial
Acronym
Study hypothesis
Aim of this study is to evaluate the effectiveness of a brief self-management intervention for employees apart and on top of an environmental intervention.
Hypotheses are that the self-management intervention will help participants:
1. To increase healthy diet and maintain weight or, if appropriate (for overweight individuals who want to lose weight), promote weight loss.
2. To improve their self-regulatory skills.
Ethics approval
In this intervention participants were taught a skill that they can implement as they wish. No behavioural guidelines were imposed on participants nor were they subjected to any kind of medical treatment. Naturally, participation in any part of the study or course was completely voluntary, and participants were well informed of all aspects of the study.
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
Four study arms: 2 (self-management intervention or active control) x 2 (either or not environmental intervention) design with three points of measurement (baseline, and 2 follow-up)
1. Self-management course Healthy Eating at Work, aimed at improving self-regulatory competence.
2. Environmental intervention: restaurant adjustments: minor adjustments were made to the presentation of unhealthy foods in the company restaurants. Unhealthy foods in the company restaurant were made less accessible by increasing distance.
The total duration of the course is approximately 2 months. The first follow-up measure is after the course is completed (3 months after the baseline questionnaire) , the second follow-up measure is taken 9 months after course completion.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Proactive coping competence: assessed using the Utrecht Proactive Coping Competence questionnaire (UPCC). The UPCC contains 21 items answered on a 4-point scale from 1 (not at all able) to 4 (very able).
2. Food intake (healthy and unhealthy): participants filled in a food diary on seven consecutive days. On each day, participants indicated for 26 food categories (e.g., fruit) whether they had eaten a product from that category. Number of meals was also assessed.
3. Snack habits: measured using the Self-Report Habit Index (SRHI). Responses on the twelve items range from 1 (completely agree) to 5 (completely disagree).
4. Body Mass Index: Participants weight was measured. Body Mass Index (BMI) was computed by dividing weight by the square of self-report height
5. Waist circumference: Participants waist circumference was measured following the Dutch Nutrition Center guidelines
Measured at baseline and first follow-up, 3 months after the baseline questionnaire and the second follow-up, 9 months after course completion.
Secondary outcome measures
1. Self-regulation strategies: self-rgulation strategies was assessed using the Tempest Self- Regulation Questionnaire for Eating (TESQ-E). The scale contains 24 items assessing how often they employ a regulation strategy, answered on a 7-point scale 1 (never) to 7 (always).
2. Self-efficacy: Self-efficacy was assessed using the Eating during Socially Acceptable Circumstances subscale of the Eating Self-Efficacy Scale. Responses on the ten items range from 1 (not difficult) to 7 (very difficult).
Measured at baseline and first follow-up, 3 months after the baseline questionnaire and the second follow-up, 9 months after course completion.
Overall trial start date
01/03/2009
Overall trial end date
01/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both men and women of all ages could participate in the study. Since we focused on a working population age is between 18 and 65 years.
2. Any company in the Netherlands that employs enough employees to form course groups could participate. Employees could participate if they were employed by a participating company and hold a motivation to actively work on healthy eating behavior. No other restrictions applied.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
440
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/03/2009
Recruitment end date
01/07/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Heidelberglaan 1
Utrecht
3584 CS
Netherlands
Sponsor information
Organisation
Utrecht University (Netherlands)
Sponsor details
c/o Denise de Ridder
Heidelberglaan 1
Utrecht
3584 CS
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Stichting Instituut GAK (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list